Meriden Company Delayed Again In Efforts To Test Aids Vaccine

November 11, 1993|By MICHAEL REMEZ; Courant Staff Writer

WASHINGTON — Buried deep in the defense spending bill approved by Congress Wednesday is a provision that could alter the fortunes of a Meriden biotechnology company hoping to market a vaccine for AIDS.

The provision adds another delay in what has turned out to be a year of delays in getting a bigger trial of the vaccine made by MicroGeneSys Inc. The company calls the gp160 vaccine the most promising of a small field of candidates, but many leading AIDS researchers see more hype than substance in the preliminary scientific results.

In 1992, lobbyists for MicroGeneSys succeeded in adding language to that year's bill that set aside $20 million for the Army to test the company's vaccine. But the measure included an out -- the Department of Defense, the National Institutes of Health and the Food and Drug Administration had six months to decide whether the money could be put to better use for wider-ranging AIDS research.

That time period passed in April, and planning for the large-scale clinical tests is still under way. But the amendment included in the defense bill for the new fiscal year will force a second look.

The amendment gives the agencies until April 5 to certify to Congress whether the money should go for some other use.

U.S. Rep. Henry A. Waxman, D-Calif., the amendment sponsor, has said officials of the three agencies have told him they do not think the trial should go forward as planned.

"I do not believe that we should force these agencies to carry out research that none of them believes to be valid," Waxman said recently. "The Congress should not be in the business of picking commercial products to test, especially in a situation as critical as the AIDS epidemic."

The original allocation outraged many AIDS activists and scientists, who argued that effective lobbying had taken the place of scientific analysis in deciding how government research dollars would be spent. But the company and its supporters characterized

the opposition as more worried about maintaining medical research turf and power in the fight against the deadly disease.

In recent months, the debate has quietly played itself out again, but this time MicroGeneSys did not fare as well.

"The most serious consequence of this delay is that millions of HIV-positive people worldwide will have to wait yet even longer before they learn whether the promise that gp160 has shown in earlier tests will be confirmed in the final Phase III trials," said a statement from the office of Franklin Volvovitz, president of MicroGeneSys.

MicroGeneSys has been waiting to start the next round of clinical trials, known as Phase III, on its vaccine. The drug has shown promise in recent foreign tests, said the prepared statement, released Wednesday. Volvovitz, could not be reached for comment.

Opponents of the funding expressed relief that the agencies had been given more time to decide whether to go ahead with the trial.

Derek Hodel is treatment issues director for the AIDS Action Council, a lobbying group based in Washington. The council has been outspoken in its opposition to funds being earmarked for MicroGeneSys and its criticism of the way former U.S. Sen. Russell Long of Louisiana, now a powerful lobbyist, was able to work the trial into last year's defense bill.

"All of us are worried about the precedent that such a move would create," Hodel said Wednesday. "We don't want Congress deciding how the research agenda should be determined. The MicroGeneSys lobbying effort was really an egregious example of inappropriate influence on the research agenda."

Mervyn Silverman, a physician who serves as president of the American Foundation for AIDS Research, said the new approach makes sense. His group also had opposed testing a single vaccine.

"Hopefully, this money can be spent in the absolute best possible way," Silverman said. "We are dealing with such scarce resources that all of us want to be sure every dollar spent is well spent."

But others argue that the Army already has started preliminary testing of the vaccine known as VaxSyn, and that the decision on additional funding should wait until the preliminary findings can be reviewed.

Shepherd Smith, president of Americans for a Sound AIDS/HIV Policy -- another Washington-based group, doesn't buy the argument of critics of the MicroGeneSys vaccine allocation that Waxman's amendment allows the scientific community to decide where funding goes.

"For those who criticized the government for getting involved in politics in respect to regulating science [by earmarking money for the MicroGeneSys vaccine trial], virtually the same thing has been done again," Smith said. "Our preference would have been to allow science to be science."

In a recent interview, Waxman made a similar point, though to a different end.

"If the scientists in charge of the research believe that this research should go forward and is of high quality, then by all means they should be allowed to fund it," he said. "But that is their job, not the job of lobbyists and politicians."

Waxman's amendment passed easily in the House. The Senate did not adopt similar language when it passed its defense appropriations bill, but the provision was added during the

conference committee.

None of the Connecticut delegation members appear to have played a role in the deliberations. Staff members said the state's two senators and U.S. Rep. Gary Franks, R-5th District, whose district includes Meriden, concentrated more on other appropriations within the defense package